October 16, 2008
DiaKine Therapeutics Advances Diabetes Drug into Phase II Study
DiaKine Therapeutics, a development-stage company commercializing immune modulators for the treatment of diabetes and related complications, has announced that a Phase II clinical trial with the company's lead drug candidate, Lisofylline, is underway.
The trial is part of the Clinical Islet Transplantation (CIT) Consortium created by National Institutes of Health (NIH). The protocol, CIT-02, will focus on treating islets pre-transplant, and recipients - during and post-transplant - with Lisofylline (LSF).
The primary objective of this study is to determine the proportion of patients who become insulin independent at 75 plus or minus five days post-transplant with a single islet infusion, the standard islet transplant regimen (a modified Edmonton Protocol) and the addition of LSF. LSF will be compared, as a secondary analysis, to subjects in a concurrent Phase III protocol, CIT-07, which uses only the standard immunosuppressive regimen.
Secondary efficacy endpoints include a percent reduction in insulin requirements, measurements of HbA1c and C-peptide/glucose x creatinine. Islets will be processed at the University of Miami (UM), and recipients will be recruited and transplanted at the UM. The secondary site for this study will be at the University of Chicago in Illinois.
Keith Ignotz, president and CEO for DiaKine Therapeutics, said: "DiaKine is honored to be part of this major collaborative effort from the NIH, and in particular have our lead drug candidate, LSF, selected by the UM for inclusion as one of the new test agents. We also wish to thank the Type 1 diabetes rapid access to intervention development program of The National Institute of Diabetes and Digestive and Kidney Diseases for producing the clinical trial supplies for the study."